Plasma Profile of Exclusively Breastfed Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-12-31

Brief Summary

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To characterize nutrient levels in breastfeeding infants and their mothers.

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Detailed Description

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The objectives of this study are (1) to characterize plasma lutein levels in breastfed infants in an Asian population where lactating mothers have diets habitually high in lutein and (2) investigate how blood lutein levels in breastfed infants vary according to lutein content of the mothers' milk in such a population.

Conditions

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Breast Fed Infants

Study Design

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Observational Model Type

FAMILY_BASED

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Infant is judged to be in good health.
* Infant is a singleton from a full term birth.
* Infant's birth weight was \> 2490 g.
* Infant is between 6 weeks and 16 weeks (42 to 112 days).
* Infant must have been exclusively breastfed at enrollment.
* Mother's intake indicates a consumption of an average of at least three servings of fruit and/or vegetables per day.
* Mother is a non-smoker.
* Mother is in good health.
* Mother confirms her intention to continue breastfeeding.

Exclusion Criteria

* An adverse maternal, fetal or infant medical history that is thought to have potential for effects on growth, and/or development.
* Infants who have consumed medications or herbal preparations during past 14 days prior to enrollment.
* Infants who have consumed any solid or liquid foods or juices prior to enrollment.
* Infants who have received any supplements containing carotenoids prior to enrollment.
* Mother who is consuming dietary supplements containing carotenoids.
* Participation in another study that has not been approved as a concomitant study.

Minimum Eligible Age

6 Weeks

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes